06 October 2021
Quality Assurance Manager

ttg has been engaged by our valued Biotech company to help find their next Manager of Quality of Assurance.
 
Manage the overall operation of the Quality Assurance (QA) process, including Donor Eligibility Determination and Final Release of product. Ensure that all donor and batch release responsibilities are performed in accordance with current Standard Operating Procedures and in compliance with federal, state, and local regulations in addition to pertaining accrediting agencies. Manages the continuous review and inspection of donor chart records ensuring the medical record documentation and processing record documentation are assembled compliantly, reviewed and completed in a timely manner. Communicate and coordinate effectively with other departments to meet production and sales needs. Prepare and report on functional area metric.
 
Duties and Responsibilities:
  1. Ensure compliance with tissue banking regulatory standards including AATB standards, FDA regulations and applicable state requirement
  2. Maintain knowledge of all QA procedures and processes related to donor and tissue tracking systems, current donor acceptance criteria, donor eligibility determination procedures, batch release procedures, and assists in their review and
  3. Develop , maintain, and report to senior management performance and release
  4. Develop and maintain tracking mechanisms for donors shared with partner agencies to ensure timely chart review and Provide reports to senior management when requested.
  5. Attend weekly planning meeting as the Quality Assurance representative and work with Operations, Customer Service, Distribution and all other cross functional department s to ensure commitments and customer needs are
  6. Complete nonconformance and corrective and preventive action report s as needed . Support investigation completion of com plaint and adverse reaction reports as necessary.
  7. Participate in internal and external audits and audit
  8. Interview, hire, train, evaluate and counsel
  9. Perform other duties as deemed necessary.
Qualifications:
Bachelor's degree in a medical or science related field preferred. Two years of experience in Quality Assurance in tissue banking, organ procurement or other related healthcare industry preferred. Excellent interpersonal, telephone, verbal and written communication skills required. Must have experience supervising staff in a manner conductive to top performance and high morale. Must be detail oriented, organized, accurate, and able to multi-task, problem solve and give recommendations. Knowledge of Good Manufacturing Practice and Good Tissue Practice regulations preferred.
 
 
 
Direct reports:
Donor Eligibility Team Lead, Donor Eligibility Specialist, Final Release Team Lead, Final Release Specialist
 
 
At ttg, "We believe in making a difference One Person at Time," ttg OPT.